SAN DIEGO, CA--(Marketwired - April 04, 2013) - Vital Therapies, Inc., a development-stage biotechnology company focused on developing the first bio-artificial liver for life-threatening acute liver failure, today announced enrollment of the first patient in a phase 3 trial designated VTI-208. The patient was enrolled at Emory University Hospital in Atlanta, Georgia last month.
VTI-208 is a randomized, open-label, multicenter, controlled trial comparing the company's investigational bio- artificial liver support system, ELAD® plus standard-of-care, versus standard-of-care alone in 200 patients with alcohol-induced liver decompensation. The primary endpoint is ninety-day overall survival and the safety and tolerability of the two treatment groups will also be compared. Patients will also be followed for 5 years in an extension protocol that will gather further survival, transplant, and other health data. Several other centers that will participate in the study are also already open for patient enrollment, and the company anticipates the study to open up 25 clinical sites by year-end.
Dr. Ram Subramanian, a transplant hepatologist and intensivist at Emory University Hospital and principal investigator, said, "We are very excited to be participating in the largest-ever clinical research trial evaluating artificial liver support. Given the lack of effective therapies in this area, this is an important milestone as this clinical program, if successful, may eventually open up much-needed options for these critically ill patients."
The company received Scientific Advice from the European Medicines Agency (EMA) and U.S Food and Drug Administration (FDA) on the design and planned analysis of the VTI-208 trial. The study will be conducted at sites in the United States, Europe, and Australia. For information about enrolling in the study, please visit www.clinicaltrials.gov.
Later this year, Vital Therapies plans to initiate two other randomized, controlled Phase 3 clinical trials: VTI-210, in patients with biopsy-proven acute alcoholic hepatitis; and VTI-212, a trial in patients with fulminant hepatic failure.
Dr. Terry Winters, Vital Therapies, Inc.'s Chief Executive Officer and Co-Chairman, said, "With the benefit of a large private financing which recently closed, we are now implementing our Phase 3 program. We are grateful to our investors for their generous support, and to our investigators for their interest in evaluating our promising new investigational therapy, ELAD."
About Vital Therapies, Inc.
Vital Therapies, Inc. is a private development-stage biotechnology company based in San Diego, California. The company is developing ELAD, an investigational extracorporeal liver support system which has been studied in seven clinical trials in US, EU and Asia. Moreover, a US/EU phase 3 trial plan to support potential BLA and MAA marketing approval has received written guidance from FDA and EMA. Vital Therapies retains all rights to ELAD and has no corporate partners.
ELAD represents the first developmental stage, human allogeneic cellular therapy for life-threatening acute liver failure. The system comprises a bedside system whose central component is four cartridges containing 440 grams of immortalized human hepatoblastoma cells and 32,000 hollow fibers. The patient's plasma flows inside of the hollow fibers to allow two-way transfer of metabolites. The system has been shown to process toxins, and synthesize proteins and metabolites in ways that mimic components of normal human liver function. The ELAD cell cartridges are produced at VTI's GMP-compliant facility in San Diego, California.
About Alcohol-Induced Liver Decompensation (AILD)
AILD is a life-threatening form of liver failure precipitated by the recent ingestion of alcohol which can occur with or without chronic underlying liver disease. One common form is Acute Alcoholic Hepatitis (AAH), which represents a severe inflammatory response to toxic liver injury. AAH is associated with a 75% mortality rate in patients with severe disease who are unresponsive to standard therapy. Another form of AILD occurs in patients with chronic, yet stable underlying liver disease who experience an acute decompensation after alcohol ingestion. Therapy for AILD centers on the use of anti-inflammatory drugs such as corticosteroids and the treatment of secondary complications such as bleeding, kidney failure and hepatic coma. Since abstinence from alcohol for 6 months is considered a pre-requisite for inclusion on a liver transplant list, organ transplantation is generally not available for these patients. Each year, we estimate there are over 30,000 cases of AILD in the United States.
ELAD® is a trademark of Vital Therapies, Inc.
This press release may contain forward-looking statements, including but not limited to statements regarding current and future clinical studies in our phase 3 program, anticipated potential benefits of the ELAD® system, and ELAD®'s market launch. These statements relate to future events and are subject to risks, uncertainties and assumptions about Vital Therapies, Inc. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement. We do not undertake to update any forward-looking statements.